D-0543-2023 Class II
FDA drug recall D-0543-2023 was initiated by Baxter Healthcare Corporation on March 15, 2023 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. Affected quantity: 9,788 bags.
Recall Details
- Product Type
- Drugs
- Report Date
- May 3, 2023
- Initiation Date
- March 15, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,788 bags
Product Description
Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 3000 mL per Ambu-Flex II Container bag, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. Product Code L5B5169, NDC 0941-0411-04.
Reason for Recall
Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component.
Distribution Pattern
Nationwide in the USA
Code Information
Lot Y405201, Exp 31-Oct-2024